Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH

December 4, 2014 updated by: Livzon Pharmaceutical Group Inc.

Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China

The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subjects aged 20~35.
  • They accorded with diagnostic criteria of severe oligospermia or azoospermia.
  • They had'nt been treated with drug which could improve sperm count and quality one month before observation，otherwise,they should have a elution for 1 month before the study.

Exclusion Criteria:

  • Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma hominis were detected in their semen.
  • Subjects addicted to drug，tobacco，or alcohol.
  • Subjects had heat,chemicals,radioactive material,or toxic contact history within a year.
  • Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic drugs,or nonsteroidal anti-inflammatory drugs .
  • Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease.
  • Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for infertility .
  • Subjects did not meet the inclusion criteria, did not according to the prescribed medication, were unable to judge the efficacy ,had incomplete information, or affected the efficacy or safety judgment.
  • Subjects were IHH patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 75IU uFSH
75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months
Drug: 75IU uFSH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sperm density
Time Frame: 6 month
6 month
(A + B)grade sperm and sperm activity rate
Time Frame: 6 month
6 month
A grade sperm
Time Frame: 6 month
6 month
semen volume
Time Frame: 6 month
6 month
sex hormone levels
Time Frame: 6 month
6 month
testis volume
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Livzon Pharmaceutical Group Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIVZON-R-14-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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